Vardenafil Qualigen 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Vardenafil Qualigen 10 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Vardenafil Qualigen is and what it is used for
2. What you need to know before taking Vardenafil Qualigen
3. How to take Vardenafil Qualigen
4. Possible side effects
5. How to store Vardenafil Qualigen
6. Contents of the pack and other information

1. What Vardenafil Qualigen is and what it is used for

This medicine contains vardenafil, an active substance belonging to a group of medicines called phosphodiesterase 5 inhibitors, which are used to treat erectile dysfunction in adult men, a condition characterized by difficulty in achieving or maintaining an erection.

At least one in ten men experiences, at some point, problems in achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, alterations in muscles and blood vessels result in insufficient blood flow to the penis to achieve and maintain an erection.

Vardenafil will only work when you are sexually stimulated. This medicine reduces the action of a natural substance in the body that prevents erection. Vardenafil enables you to achieve an erection of sufficient duration to allow satisfactory sexual intercourse.

2. What you need to know before taking Vardenafil Qualigen

Do not take Vardenafil

• If you are allergic to vardenafil or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include rash, itching, swelling of the face or lips, and difficulty breathing.
• If you have ever developed a severe skin rash, peeling skin, blisters, and/or mouth sores after taking Vardenafil Qualigen.
• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina pectoris, or those that release nitric oxide, such as amyl nitrite. Taking these medicines together with vardenafil may seriously affect your blood pressure.
• If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
• If you are over 75 years old and are taking ketoconazole or itraconazole, antifungal medicines.
• If you have severe heart or liver problems.
• If you are undergoing renal dialysis.
• If you have recently had a stroke or heart attack.
• If you have low blood pressure, or have had it in the past.
• If you have a family history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have ever experienced vision loss due to optic nerve damage caused by insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). PDE5 inhibitors, such as vardenafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

Take special care with vardenafil

• If you have heart problems, as sexual activity may pose a risk to you.
• If you have irregular heartbeats (cardiac arrhythmia) or an inherited heart condition affecting your electrocardiogram.
• If you have a physical condition affecting the shape of your penis, such as curvature, Peyronie's disease, or cavernosal fibrosis.
• If you have a condition that may cause prolonged erections (priapism), such as sickle cell anemia, multiple myeloma, or leukemia.
• If you have a stomach ulcer (also known as gastric or peptic ulcer).
• If you have bleeding disorders (such as hemophilia).
• If you are using any other treatment for erectile problems, including vardenafil film-coated tablets (see section: “Use of Vardenafil with other medicines”).
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with vardenafil treatment. Discontinue treatment with Vardenafil Qualigen and seek immediate medical attention if you experience any symptoms related to these severe skin reactions described in section 4.
• If you suddenly experience a decrease or loss of vision, or if your vision becomes distorted or darkened while taking Vardenafil Qualigen, stop taking vardenafil and contact your doctor immediately.

Children and adolescents

Vardenafil must not be used in children or adolescents under 18 years of age.

Taking Vardenafil Qualigen with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Some medicines may cause problems, especially the following:

• Nitrates, medicines for angina pectoris, or those that release nitric oxide, such as amyl nitrate. Taking these medicines together with vardenafil may seriously affect your blood pressure. Do not take vardenafil without first consulting your doctor.
• Medicines used to treat cardiac arrhythmias, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV. Do not take vardenafil without first consulting your doctor.
• Ketoconazole or itraconazole, antifungal medicines.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a group of medicines used to treat high blood pressure and enlarged prostate (such as benign prostatic hyperplasia).
• Riociguat.

Do not use vardenafil film-coated tablets in combination with another medicine for the treatment of erectile dysfunction, including vardenafil orodispersible tablets.

Taking Vardenafil with food, drinks, and alcohol

• You may take vardenafil with or without food, but it is preferable not to take it after a heavy or high-fat meal, as the effect may be delayed.

• Do not drink grapefruit juice when taking vardenafil, as it may interfere with the normal effect of the medicine.

• Drinking alcoholic beverages may worsen erectile problems.

Pregnancy and breastfeeding

Vardenafil must not be used in women.

Driving and using machines

In some people, vardenafil may cause dizziness or affect vision. Do not drive or operate tools or machinery if you feel dizzy or have vision problems after taking vardenafil.

3. How to take Vardenafil Qualigen

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take one vardenafil tablet approximately 25 to 60 minutes before sexual activity. With sexual stimulation, you may achieve an erection from 25 minutes up to four or five hours after taking vardenafil.

• Swallow the tablet with a glass of water.

Do not take vardenafil film-coated tablets together with any other formulation of vardenafil.

Do not take vardenafil more than once a day.

If you feel that the effect of vardenafil is too strong or too weak, inform your doctor. Your doctor may suggest switching to another formulation of vardenafil with a different dose, depending on its effect on you.

If you take more vardenafil than you should

Taking too many vardenafil tablets may lead to increased adverse effects and cause severe back pain.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, vardenafil may cause adverse effects, although not everyone experiences them. Most of these adverse effects are mild or moderate.

Some patients have experienced sudden, temporary or permanent decrease or partial loss of vision, or distorted, dimmed or blurred central vision, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

Sudden decrease or loss of hearing has also been reported.

Cases of sudden death, rapid or irregular heartbeat, heart attack, chest pain, and cerebrovascular events (including transient reduction in blood flow to parts of the brain and cerebral hemorrhage) have been reported in men taking vardenafil. Most of the men who experienced these side effects had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

The likelihood of experiencing an adverse effect is described using the following categories:

Very common adverse effects: may affect more than 1 in 10 people:

• Headache.

Common adverse effects: may affect up to 1 in 10 people:

• Dizziness.
• Facial flushing.
• Runny or congested nose.
• Indigestion.

Uncommon adverse effects: may affect up to 1 in 100 people:

• Swelling of the skin and mucous membranes, including facial, lip or throat swelling.
• Sleep disturbances.
• Numbness and altered sense of touch.
• Somnolence.
• Visual disturbances; eye haemorrhage, disturbances in colour vision, eye pain, and photosensitivity.
• Ringing in the ears (tinnitus); vertigo.
• Fast pulse or palpitations.
• Difficulty breathing.
• Nasal congestion.
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling unwell (nausea), dry mouth.
• Increased liver enzymes in blood.
• Skin rashes, red skin.
• Back pain or muscle pain; increased blood levels of the muscle enzyme creatine phosphokinase; muscle stiffness.
• Prolonged erection.
• General malaise.

Rare adverse effects: may affect up to 1 in 1,000 people:

• Eye inflammation (conjunctivitis).
• Allergic reaction.
• Anxiety.
• Fainting.
• Amnesia (memory loss).
• Seizures.
• Glaucoma (increased intraocular pressure), watery eyes.
• Effects on the heart (e.g., myocardial infarction, tachycardia, angina).
• High or low blood pressure.
• Nosebleeds.
• Abnormal liver function test results in blood.
• Skin sensitivity to sunlight.
• Painful erection.
• Chest pain.
• Transient reduction in blood flow to parts of the brain.

Very rare or frequency unknown adverse effects: may affect fewer than 1 in 10,000 people, or frequency cannot be estimated from available data:

• Blood in urine (haematuria).
• Bleeding from the penis (penile haemorrhage).
• Blood in semen (haemospermia).
• Sudden death.
• Cerebral haemorrhage.
• Red, non-elevated, target-shaped or circular skin lesions on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Distorted, dimmed or blurred central vision or sudden decrease in vision.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, even if it is a possible side effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vardenafil Qualigen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Store this medicine below 30°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Package contents and other information

Composition of Vardenafil Qualigen

• The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride).
• The other components are:

In the tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica.

In the film coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the package

Vardenafil Qualigen 10 mg, film-coated tablets, round, biconvex, light orange in color. Each package contains 2, 4, or 8 tablets.

Only certain package sizes may be commercially available.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

Date of the most recent review of this leaflet: January 2025

Detailed information on this medicine is available on the website of the

Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.